Trial Outcomes & Findings for EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma (NCT NCT02601937)
NCT ID: NCT02601937
Last Updated: 2024-10-03
Results Overview
The incidence and severity of treatment-emergent adverse events qualifying as protocol-defined dose-limiting toxicities that occurred during the first month of treatment was used to determine the RP2D and/or maximum tolerated dose (MTD) in pediatric patients treated with tazemetostat.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
109 participants
Primary outcome timeframe
Cycle 1, from the start of study treatment (Day 1) until the end of the first Cycle (Day 28) of treatment
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
Dose Escalation Level 1
Patients with relapsed/refractory rhabdoid tumors, integrase interactor 1 (INI1)-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 240 milligrams per square meter (mg/m\^2) twice daily (BID) in continuous 28-day cycles.
|
Dose Escalation Level 2
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Expansion Cohort 1
Patients with atypical teratoid rhabdoid tumor (ATRT) who participated in the dose expansion portion of the study received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 2
Patients with malignant rhabdoid tumor (MRT)/ rhabdoid tumor of kidney (RTK)/select tumors with rhabdoid features who participated in the dose expansion portion of the study. Patients whose disease was without central nervous system (CNS) involvement received 520 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles. Patients whose disease had CNS involvement received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 3
Patients with INI-negative tumors who participated in the dose expansion portion of the study. Patients whose disease was without central nervous system (CNS) involvement received 520 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles. Patients whose disease had CNS involvement received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 4
Patients with one of the tumor types defined in Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement received 800 mg/m\^2 tazemetostat three times daily (TID) orally in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1: Dose Escalation Phase
STARTED
|
8
|
6
|
6
|
7
|
6
|
6
|
7
|
0
|
0
|
0
|
0
|
|
Period 1: Dose Escalation Phase
COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Dose Escalation Phase
NOT COMPLETED
|
8
|
6
|
6
|
6
|
6
|
5
|
7
|
0
|
0
|
0
|
0
|
|
Period 2: Dose Expansion Cohort
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
19
|
20
|
18
|
6
|
|
Period 2: Dose Expansion Cohort
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Period 2: Dose Expansion Cohort
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
18
|
20
|
18
|
5
|
Reasons for withdrawal
| Measure |
Dose Escalation Level 1
Patients with relapsed/refractory rhabdoid tumors, integrase interactor 1 (INI1)-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 240 milligrams per square meter (mg/m\^2) twice daily (BID) in continuous 28-day cycles.
|
Dose Escalation Level 2
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Expansion Cohort 1
Patients with atypical teratoid rhabdoid tumor (ATRT) who participated in the dose expansion portion of the study received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 2
Patients with malignant rhabdoid tumor (MRT)/ rhabdoid tumor of kidney (RTK)/select tumors with rhabdoid features who participated in the dose expansion portion of the study. Patients whose disease was without central nervous system (CNS) involvement received 520 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles. Patients whose disease had CNS involvement received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 3
Patients with INI-negative tumors who participated in the dose expansion portion of the study. Patients whose disease was without central nervous system (CNS) involvement received 520 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles. Patients whose disease had CNS involvement received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 4
Patients with one of the tumor types defined in Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement received 800 mg/m\^2 tazemetostat three times daily (TID) orally in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1: Dose Escalation Phase
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Dose Escalation Phase
Patient refused further treatment of study drug
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 1: Dose Escalation Phase
Unacceptable toxicity
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1: Dose Escalation Phase
Progressive disease
|
7
|
6
|
5
|
6
|
6
|
4
|
6
|
0
|
0
|
0
|
0
|
|
Period 2: Dose Expansion Cohort
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2: Dose Expansion Cohort
Patient refused further treatment of study drug
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Period 2: Dose Expansion Cohort
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Period 2: Dose Expansion Cohort
Progressive disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
17
|
14
|
4
|
|
Period 2: Dose Expansion Cohort
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
|
Period 2: Dose Expansion Cohort
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
EZH2 Inhibitor Tazemetostat in Pediatric Subjects With Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Baseline characteristics by cohort
| Measure |
Dose Escalation Level 1
n=8 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 240 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 2
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
n=7 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
n=7 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Expansion Cohort 1
n=19 Participants
Patients with ATRT who participated in the dose expansion portion of the study received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 2
n=20 Participants
Patients with MRT/ RTK/select tumors with rhabdoid features who participated in the dose expansion portion of the study. Patients whose disease was without CNS involvement received 520 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles. Patients whose disease had CNS involvement received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 3
n=18 Participants
Patients with INI-negative tumors who participated in the dose expansion portion of the study.
Patients whose disease was without CNS involvement received 520 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles. Patients whose disease had CNS involvement received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 4
n=6 Participants
Patients with one of the tumor types defined in Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement received 800 mg/m\^2 tazemetostat TID orally in continuous 28-day cycles.
|
Total
n=109 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
20 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
106 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Continuous
|
2.5 years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
11.5 years
STANDARD_DEVIATION 5.24 • n=7 Participants
|
4.6 years
STANDARD_DEVIATION 3.98 • n=5 Participants
|
4.5 years
STANDARD_DEVIATION 3.50 • n=4 Participants
|
7.0 years
STANDARD_DEVIATION 4.82 • n=21 Participants
|
4.0 years
STANDARD_DEVIATION 2.79 • n=8 Participants
|
4.8 years
STANDARD_DEVIATION 4.97 • n=8 Participants
|
4.4 years
STANDARD_DEVIATION 4.25 • n=24 Participants
|
3.4 years
STANDARD_DEVIATION 3.31 • n=42 Participants
|
12.8 years
STANDARD_DEVIATION 5.26 • n=42 Participants
|
14.7 years
STANDARD_DEVIATION 3.61 • n=42 Participants
|
6.6 years
STANDARD_DEVIATION 5.66 • n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
59 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
50 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
79 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
79 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
18 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Cycle 1, from the start of study treatment (Day 1) until the end of the first Cycle (Day 28) of treatmentPopulation: The ITT population included all patients who received at least one dose of tazemetostat.
The incidence and severity of treatment-emergent adverse events qualifying as protocol-defined dose-limiting toxicities that occurred during the first month of treatment was used to determine the RP2D and/or maximum tolerated dose (MTD) in pediatric patients treated with tazemetostat.
Outcome measures
| Measure |
Overall Dose Escalation
n=46 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat at BID dose level 1: 240 mg/m\^2, dose level 2: 300 mg/m\^2, dose level 3: 400 mg/m\^2, dose level 4: 520 mg/m\^2, dose level 5: 700 mg/m\^2, dose level 6: 900 mg/m\^2 and dose level 7: 1200 mg/m\^2 in continuous 28-day cycles.
|
Dose Escalation Level 2
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|
|
Recommended Phase 2 Dose (RP2D) (Dose Escalation Only)
RP2D for patients with ATRT or CNS involvement
|
1200 mg/m^2 BID
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Recommended Phase 2 Dose (RP2D) (Dose Escalation Only)
RP2D for patients without CNS involvement
|
520 mg/m^2 BID
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1, from the start of study treatment (Day 1) until the end of the first Cycle (Day 28) of treatmentPopulation: Dose-Limiting Toxicity (DLT) population included all patients in the safety population set who experienced a DLT during Cycle 1 or were not removed from Cycle 1 for reasons other than toxicity and did not have an interruption in study treatment for more than 14 days during Cycle 1. Only those patients with data collected at Cycle 1 are reported.
The RP2D in pediatric patients treated with tazemetostat as determined by the incidence and severity of treatment-emergent adverse events qualifying as protocol-defined dose-limiting toxicities that occurred during the first month of treatment.
Outcome measures
| Measure |
Overall Dose Escalation
n=5 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat at BID dose level 1: 240 mg/m\^2, dose level 2: 300 mg/m\^2, dose level 3: 400 mg/m\^2, dose level 4: 520 mg/m\^2, dose level 5: 700 mg/m\^2, dose level 6: 900 mg/m\^2 and dose level 7: 1200 mg/m\^2 in continuous 28-day cycles.
|
Dose Escalation Level 2
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|
|
Number of Dose-limiting Toxicities (Dose Escalation Only)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: RECIST assessments performed at screening (within 14 days before start of study intervention) and every 8 weeks post start of dosing, approximately up to 302 weeksPopulation: The ITT population included all patients who received at least one dose of tazemetostat.
ORR is defined as the percentage of patients who achieved a confirmed complete response (CR) and/or partial response (PR) defined by response evaluation criteria in solid tumors (RECIST) or response assessment in neuro-oncology (RANO) criteria from the start of tazemetostat treatment until disease progression or the start of subsequent anticancer therapy, whichever occurs first. CR is defined as disappearance of all target and non-target lesions (with all lymph nodes must be non-pathological in size or under 10 millimeters \[mm\] in short axis) and PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR= CR+PR.
Outcome measures
| Measure |
Overall Dose Escalation
n=19 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat at BID dose level 1: 240 mg/m\^2, dose level 2: 300 mg/m\^2, dose level 3: 400 mg/m\^2, dose level 4: 520 mg/m\^2, dose level 5: 700 mg/m\^2, dose level 6: 900 mg/m\^2 and dose level 7: 1200 mg/m\^2 in continuous 28-day cycles.
|
Dose Escalation Level 2
n=20 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
n=18 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR) (Dose Expansion Only)
|
26.3 Percentage of participants
|
0 Percentage of participants
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: RECIST assessments performed at screening (within 14 days before start of study intervention) and every 8 weeks post start of dosing, approximately up to 302 weeksPopulation: The ITT population included all patients who received at least one dose of tazemetostat.
ORR is defined as the percentage of patients who achieved a confirmed CR and/or PR defined by RECIST or RANO criteria from the start of tazemetostat treatment until disease progression or the start of subsequent anticancer therapy, whichever occurs first. CR is defined as disappearance of all target and non-target lesions (with all lymph nodes must be non-pathological in size or under 10 mm in short axis) and PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR= CR+PR.
Outcome measures
| Measure |
Overall Dose Escalation
n=8 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat at BID dose level 1: 240 mg/m\^2, dose level 2: 300 mg/m\^2, dose level 3: 400 mg/m\^2, dose level 4: 520 mg/m\^2, dose level 5: 700 mg/m\^2, dose level 6: 900 mg/m\^2 and dose level 7: 1200 mg/m\^2 in continuous 28-day cycles.
|
Dose Escalation Level 2
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
n=7 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
n=7 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|
|
ORR (Dose Escalation Only)
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
14.3 Percentage of participants
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: RECIST assessments performed at screening (within 14 days before start of study intervention) and every 8 weeks post start of dosing, approximately up to 302 weeksPopulation: The ITT population included all patients who received at least one dose of tazemetostat.
PFS was defined as the interval of time (in weeks) from the date of first dose of study drug and the earliest date of disease progression or death, from any cause defined by RECIST or RANO criteria. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (including at least a 5 mm absolute increase). The presence of new lesions also constitutes to disease progression.
Outcome measures
| Measure |
Overall Dose Escalation
n=19 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat at BID dose level 1: 240 mg/m\^2, dose level 2: 300 mg/m\^2, dose level 3: 400 mg/m\^2, dose level 4: 520 mg/m\^2, dose level 5: 700 mg/m\^2, dose level 6: 900 mg/m\^2 and dose level 7: 1200 mg/m\^2 in continuous 28-day cycles.
|
Dose Escalation Level 2
n=20 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
n=18 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) (Dose Expansion Only)
|
7.9 weeks
Interval 6.0 to 24.3
|
7.7 weeks
Interval 3.4 to 8.0
|
15.9 weeks
Interval 8.0 to 21.3
|
28.3 weeks
Interval 7.9 to 145.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: RECIST assessments performed at screening (within 14 days before start of study intervention) and every 8 weeks post start of dosing, approximately up to 302 weeksPopulation: The ITT population included all patients who received at least one dose of tazemetostat.
Overall survival was defined as the time (in weeks) from the first dose of study drug to the date of death due to any cause.
Outcome measures
| Measure |
Overall Dose Escalation
n=19 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat at BID dose level 1: 240 mg/m\^2, dose level 2: 300 mg/m\^2, dose level 3: 400 mg/m\^2, dose level 4: 520 mg/m\^2, dose level 5: 700 mg/m\^2, dose level 6: 900 mg/m\^2 and dose level 7: 1200 mg/m\^2 in continuous 28-day cycles.
|
Dose Escalation Level 2
n=20 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
n=18 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
n=6 Participants
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (Dose Expansion Only)
|
21.4 weeks
Interval 11.0 to 50.3
|
14.1 weeks
Interval 6.9 to 22.4
|
41.8 weeks
Interval 18.6 to 55.6
|
103.1 weeks
Interval 12.3 to 185.6
|
—
|
—
|
—
|
Adverse Events
Dose Escalation Level 1
Serious events: 4 serious events
Other events: 8 other events
Deaths: 7 deaths
Dose Escalation Level 2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 6 deaths
Dose Escalation Level 3
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Dose Escalation Level 4
Serious events: 2 serious events
Other events: 7 other events
Deaths: 4 deaths
Dose Escalation Level 5
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Dose Escalation Level 6
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Dose Escalation Level 7
Serious events: 2 serious events
Other events: 6 other events
Deaths: 7 deaths
Dose Expansion Cohort 1
Serious events: 12 serious events
Other events: 19 other events
Deaths: 15 deaths
Dose Expansion Cohort 2
Serious events: 10 serious events
Other events: 19 other events
Deaths: 18 deaths
Dose Expansion Cohort 3
Serious events: 9 serious events
Other events: 18 other events
Deaths: 16 deaths
Dose Expansion Cohort 4
Serious events: 3 serious events
Other events: 6 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dose Escalation Level 1
n=8 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 240 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 2
n=6 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
n=6 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
n=7 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
n=6 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
n=6 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
n=7 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Expansion Cohort 1
n=19 participants at risk
Patients with ATRT who participated in the dose expansion portion of the study received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 2
n=20 participants at risk
Patients with MRT/ RTK/select tumors with rhabdoid features who participated in the dose expansion portion of the study. Patients whose disease was without CNS involvement received 520 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles. Patients whose disease had CNS involvement received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 3
n=18 participants at risk
Patients with INI-negative tumors who participated in the dose expansion portion of the study.
Patients whose disease was without CNS involvement received 520 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles. Patients whose disease had CNS involvement received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 4
n=6 participants at risk
Patients with one of the tumor types defined in Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement received 800 mg/m\^2 tazemetostat TID orally in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Visual impairment
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Disease progression
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Central Nervous System Ventriculitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Device related infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Mastoid abscess
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Otitis media
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Pneumococcal bacteraemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
9.1%
1/11 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Bronchitis
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rhabdoid tumour
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
21.1%
4/19 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Seizure
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
15.0%
3/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Vascular disorders
Superior vena cava syndrome
|
12.5%
1/8 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
Other adverse events
| Measure |
Dose Escalation Level 1
n=8 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 240 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 2
n=6 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 300 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 3
n=6 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 400 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 4
n=7 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 520 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 5
n=6 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 700 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 6
n=6 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 900 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Escalation Level 7
n=7 participants at risk
Patients with relapsed/refractory rhabdoid tumors, INI1-negative tumors, or synovial sarcoma with SS18-SSX rearrangement received oral tazemetostat 1200 mg/m\^2 BID in continuous 28-day cycles.
|
Dose Expansion Cohort 1
n=19 participants at risk
Patients with ATRT who participated in the dose expansion portion of the study received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 2
n=20 participants at risk
Patients with MRT/ RTK/select tumors with rhabdoid features who participated in the dose expansion portion of the study. Patients whose disease was without CNS involvement received 520 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles. Patients whose disease had CNS involvement received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 3
n=18 participants at risk
Patients with INI-negative tumors who participated in the dose expansion portion of the study.
Patients whose disease was without CNS involvement received 520 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles. Patients whose disease had CNS involvement received 1200 mg/m\^2 open-label, tazemetostat BID orally in continuous 28-day cycles.
|
Dose Expansion Cohort 4
n=6 participants at risk
Patients with one of the tumor types defined in Cohorts 1 through 3 or synovial sarcoma with SS18-SSX rearrangement received 800 mg/m\^2 tazemetostat TID orally in continuous 28-day cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Peripheral swelling
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Otitis media
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
15.8%
3/19 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
12.5%
1/8 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
85.7%
6/7 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
57.9%
11/19 • Number of events 19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
45.0%
9/20 • Number of events 14 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
61.1%
11/18 • Number of events 34 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
83.3%
5/6 • Number of events 19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
21.1%
4/19 • Number of events 29 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
40.0%
8/20 • Number of events 18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
27.8%
5/18 • Number of events 13 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 10 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
26.3%
5/19 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
20.0%
4/20 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
22.2%
4/18 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
15.8%
3/19 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Irritability
|
37.5%
3/8 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
21.1%
4/19 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
38.9%
7/18 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Paraesthesia
|
12.5%
1/8 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
31.6%
6/19 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
25.0%
5/20 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
61.1%
11/18 • Number of events 16 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
15.0%
3/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
31.6%
6/19 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
20.0%
4/20 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
6/18 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
20.0%
4/20 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
66.7%
4/6 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
36.8%
7/19 • Number of events 12 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
15.0%
3/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
38.9%
7/18 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
20.0%
4/20 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
15.0%
3/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
3/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
22.2%
4/18 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
21.1%
4/19 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
25.0%
5/20 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
38.9%
7/18 • Number of events 16 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
21.1%
4/19 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
27.8%
5/18 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
27.8%
5/18 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Lymphocyte count decreased
|
12.5%
1/8 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
15.0%
3/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Weight decreased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
15.0%
3/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Blood bromide increased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
50.0%
3/6 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
28.6%
2/7 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Oral candidiasis
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Candida infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 5 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Skin infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Viral rash
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Impetigo
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Skin candida
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Body tinea
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
COVID-19
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Device related infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritumoural oedema
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
2/8 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Behaviour disorder
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Fear
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Dysmetria
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Auditory nerve disorder
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Facial nerve disorder
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
IVth nerve paralysis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Drooling
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Neuromyopathy
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Seizure
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Nervous system disorders
VIth nerve disorder
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Cardiac disorders
Defect conduction intraventricular
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Vascular disorders
Embolism
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Vascular disorders
Hot flush
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Yawning
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.0%
2/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Tongue erythema
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Tooth development disorder
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Blister
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Bacterial test positive
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Facial asymmetry
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Gait disturbance
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Catheter site swelling
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Chest pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Chills
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Face oedema
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Feeling cold
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Localised oedema
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Malaise
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Catheter site pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Axillary pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Catheter site erosion
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
General disorders
Generalised oedema
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Weight increased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
11.1%
2/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Eye disorders
Dry eye
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Eye disorders
Eye pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Eye disorders
Eyelid function disorder
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Eye disorders
Corneal epithelium defect
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Eye disorders
Exophthalmos
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Renal and urinary disorders
Urinary incontinence
|
12.5%
1/8 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Eye disorders
Gaze palsy
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Eye disorders
Neurotrophic keratopathy
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Eye disorders
Papilloedema
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Eye disorders
Photophobia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
33.3%
2/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
10.5%
2/19 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
External ear inflammation
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
Deafness transitory
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Reproductive system and breast disorders
Vulvovaginal rash
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.3%
1/19 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/18 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/8 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/6 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/7 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/19 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
5.6%
1/18 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
16.7%
1/6 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from the time of the first dose of study treatment (Day 1) until the earlier of either 30 days after the discontinuation of study treatment or until the initiation of subsequent anticancer therapy, approximately 114 weeks (dose escalation phase) and 138.7 weeks (dose expansion phase). All-cause mortality (deaths) were collected from the time of the first dose of study treatment (Day 1) up to 302 weeks.
The safety population consists of all patients in the ITT population who had at least one post-dose safety observation recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60