Trial Outcomes & Findings for A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer (NCT NCT04699630)
NCT ID: NCT04699630
Last Updated: 2026-05-22
Results Overview
Overall Response Rate (ORR) is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) out of all treated participants. Confirmed response is two consecutive CR or PR at least 4 weeks apart according to RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of lesion diameters.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.
Results posted on
2026-05-22
Participant Flow
Participant milestones
| Measure |
Part A
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative participants were enrolled into this arm.
|
Part B
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
40
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
60
|
40
|
21
|
Reasons for withdrawal
| Measure |
Part A
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative participants were enrolled into this arm.
|
Part B
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Overall Study
Disease Progression by RECIST v1.1
|
38
|
28
|
18
|
|
Overall Study
Clinical Progression/Symptomatic Deterioration
|
5
|
3
|
2
|
|
Overall Study
Adverse Event
|
13
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
0
|
|
Overall Study
Non-compliance to Protocol
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
3
|
0
|
Baseline Characteristics
A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Part A
n=60 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into this arm.
|
Part B
n=40 Participants
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
n=21 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 Years
n=2 Participants
|
57 Years
n=4 Participants
|
56 Years
n=6 Participants
|
57 Years
n=8 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=2 Participants
|
40 Participants
n=4 Participants
|
21 Participants
n=6 Participants
|
120 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=2 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=6 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=6 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=2 Participants
|
31 Participants
n=4 Participants
|
14 Participants
n=6 Participants
|
91 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=6 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=2 Participants
|
40 Participants
n=4 Participants
|
21 Participants
n=6 Participants
|
121 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.Population: Comprised of all participants who received at least one dose of study treatment in Part A and Part B (HER2-negative participants).
Overall Response Rate (ORR) is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) out of all treated participants. Confirmed response is two consecutive CR or PR at least 4 weeks apart according to RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of lesion diameters.
Outcome measures
| Measure |
Part A
n=60 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into Part A.
|
Part B
n=40 Participants
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Overall Response Rate (ORR) in Participants With HER2-negative MBC (Part A and Part B)
|
35 percentage of participants
Interval 23.1 to 48.4
|
5 percentage of participants
Interval 0.6 to 16.9
|
—
|
PRIMARY outcome
Timeframe: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.Population: Comprised of all participants who received at least one dose of study treatment in Part A and Part B (HER2-negative participants).
Progression-Free Survival at 6 months (PFS-6) is defined as the rate of patients who survive progression-free for at least 6 months per RECIST version (v) 1.1. Per RECIST V1.1, progressive disease is defined as a ≥20% increase in target lesions and ≥5mm increase in size from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Part A
n=60 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into Part A.
|
Part B
n=40 Participants
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Progression-Free Survival at 6 Months (PFS-6) in Participants With HER2-negative MBC (Part A and Part B)
|
43.3 percentage of participants
Interval 30.6 to 56.8
|
10.0 percentage of participants
Interval 2.8 to 23.7
|
—
|
SECONDARY outcome
Timeframe: Every 3 weeks, up to 45 months.Population: Comprised of all participants who received at least one dose of study treatment.
The safety and tolerability of U3-1402 (Patritumab Deruxtecan) was assessed through the analysis of the reported incidence of treatment-emergent AEs. Treatment-emergent AEs are those with an onset on or after the initiation of study therapy up to 40 days after last day of treatment, and will be graded according to NCI CTCAE 5.0.
Outcome measures
| Measure |
Part A
n=60 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into Part A.
|
Part B
n=40 Participants
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
n=21 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Incidence of Treatment- Emergent Adverse Events to Assess Safety and Tolerability
|
60 Participants
|
39 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.Population: Duration of response analysis will only include responders (CR or PR) from Part A, Part B, and Part Z as the calculation is only for participants who have had CR or PR.
Duration of response (DOR) is calculated only for participants who experienced a Complete Response (CR) or Partial Response (PR) per RECIST V1.1 and is defined as the median number of months of duration from the first documented response \[complete response (CR) or partial response (PR)\] to the date of disease progression (PD) according to the RECIST V1.1 criteria or death due to any cause. Per RECIST V1.1, CR=disappearance of all target lesions, PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of target lesion diameters, PD is ≥20% increase in target lesions and ≥5mm from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions. Kaplan-Meier estimates were used to calculate the 95% confidence intervals for duration of response.
Outcome measures
| Measure |
Part A
n=21 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into Part A.
|
Part B
n=2 Participants
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
n=1 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Duration of Response (DOR)
|
7.5 months
Interval 5.4 to 10.3
|
3.6 months
Interval 2.8 to
The upper limit of the 95% confidence interval is not estimable by Kaplan-Meier method due to insufficient number of participants with events.
|
4.3 months
The upper and lower limit of the 95% confidence internal by Kaplan-Meier method is not estimable by Kaplan-Meier method due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.Population: Comprised of all participants who received at least one dose of study treatment- Part A, Part B, and Part Z.
Progression Free Survival (PFS) is defined as the time from start of study treatment to the date of the first documented disease progression (PD) according to the RECIST V1.1 criteria or death due to any cause. Per RECIST V1.1, PD is ≥20% increase in target lesions and ≥5mm increase from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Part A
n=60 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into Part A.
|
Part B
n=40 Participants
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
n=21 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Progression-Free Survival (PFS)
|
7.2 months
Interval 4.0 to 10.2
|
2.6 months
Interval 1.4 to 3.7
|
1.4 months
Interval 1.3 to 3.1
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.Population: Comprised of all participants who received at least one dose of study treatment in Part A, Part B, and Part Z.
CBR is defined as the rate of participants with complete response (CR), partial response (PR), or best overall response of stable disease (SD) for ≥ 6 months according to the RECIST v 1.1 criteria. Per RECIST V1.1: A CR is defined as the disappearance of all target and non-target lesions. A PR is defined as ≥30% decrease in the sum of diameters of target lesions from the baseline sum. A SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).
Outcome measures
| Measure |
Part A
n=60 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into Part A.
|
Part B
n=40 Participants
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
n=21 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
48.3 percentage of participants
Interval 35.2 to 61.6
|
5.0 percentage of participants
Interval 0.6 to 16.9
|
4.8 percentage of participants
Interval 0.1 to 23.8
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.Population: Comprised of all participants who received at least one dose of study treatment in Part Z (HER2- positive).
Overall Response Rate (ORR) is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) out of all treated participants. Confirmed response is two consecutive CR or PR at least 4 weeks apart according to RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of lesion diameters.
Outcome measures
| Measure |
Part A
n=21 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into Part A.
|
Part B
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Overall Response Rate (ORR) in Participants With HER2-positive (HER2+) MBC After Progression on Trastuzumab Deruxtecan: Part Z
|
4.8 percentage of participants
Interval 0.1 to 23.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks for the first 6 months then every 9 weeks thereafter until disease progression or death or study discontinuation, up to 45 months.Population: Comprised of all participants who received at least one dose of study treatment in Part
Progression-Free Survival at 6 months (PFS-6) is defined as the rate of patients who survive progression-free for at least 6 months per RECIST version (v) 1.1. Per RECIST V1.1, progressive disease is defined as a ≥20% increase in target lesions and ≥5mm increase in size from smallest sum, appearance of any new lesions, or unequivocal progression of non-target lesions.
Outcome measures
| Measure |
Part A
n=21 Participants
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into Part A.
|
Part B
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Progression-Free Survival at 6 Months (PFS-6) in Participants With HER2-positive (HER2+) MBC: Part Z
|
0 percentage of participants
Interval 0.0 to 16.1
|
—
|
—
|
Adverse Events
Part A
Serious events: 12 serious events
Other events: 60 other events
Deaths: 7 deaths
Part B
Serious events: 7 serious events
Other events: 39 other events
Deaths: 4 deaths
Part Z
Serious events: 5 serious events
Other events: 21 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part A
n=60 participants at risk
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into Part A.
|
Part B
n=40 participants at risk
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
n=21 participants at risk
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Nausea
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
General disorders and administration site conditions
Fatigue
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Infections and infestations
COVID-19
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Infections and infestations
Eye infection
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Infections and infestations
Skin infection
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Platelet count decreased
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
2/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
Other adverse events
| Measure |
Part A
n=60 participants at risk
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. All participants will undergo pre-treatment biopsies (An archival tissue sample taken within two months of treatment should be provided if it is not medically feasible to provide a pre-treatment biopsy). 60 HER2-negative metastatic breast cancer participants were enrolled into Part A.
|
Part B
n=40 participants at risk
Participants will receive 5.6 mg/kg U3-1402 intravenously on day 1 every 3 weeks. Part B enrolled 20 participants with hormone-receptor positive (HR+) HER2-negative metastatic breast cancer and 20 participants with metastatic triple-negative breast cancer (mTNBC), regardless of HER3 expression.
|
Part Z
n=21 participants at risk
Participants will receive 5.6 mg/kg U3-1402 (Patritumab Deruxtecan) intravenously on day 1 every 3 weeks. Part Z enrolled 21 participants with HER2-positive (HER2+) metastatic breast cancer (MBC).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
20/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
20.0%
8/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
19.0%
4/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
4/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Cardiac disorders
Sinus tachycardia
|
3.3%
2/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Eye disorders
Dry eye
|
10.0%
6/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Eye disorders
Vision blurred
|
15.0%
9/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
5/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.7%
7/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
2/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
15/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
17.5%
7/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
23.8%
5/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
43.3%
26/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
22.5%
9/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
33.3%
7/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
7.5%
3/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
2/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
7.5%
3/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.7%
7/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Nausea
|
55.0%
33/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
42.5%
17/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
52.4%
11/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
5/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
21/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
27.5%
11/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
19.0%
4/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
General disorders and administration site conditions
Chills
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
General disorders and administration site conditions
Fatigue
|
48.3%
29/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
37.5%
15/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
23.8%
5/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
General disorders and administration site conditions
Oedema peripheral
|
13.3%
8/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
General disorders and administration site conditions
Pyrexia
|
10.0%
6/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Infections and infestations
COVID-19
|
13.3%
8/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
5/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
10/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
6/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
9/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
6/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
12.5%
5/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Blood bilirubin increased
|
8.3%
5/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.7%
4/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Lymphocyte count decreased
|
8.3%
5/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
7.5%
3/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Neutrophil count decreased
|
21.7%
13/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
32.5%
13/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
33.3%
7/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Platelet count decreased
|
13.3%
8/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
15.0%
6/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
14.3%
3/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
Weight decreased
|
13.3%
8/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Investigations
White blood cell count decreased
|
13.3%
8/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
30.0%
12/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
19.0%
4/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.3%
11/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
22.5%
9/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.7%
7/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
14.3%
3/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
4/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
10.0%
6/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
14.3%
3/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.3%
2/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
7.5%
3/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
31.7%
19/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
20.0%
8/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
23.8%
5/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.3%
5/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
7.5%
3/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
11.7%
7/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.7%
7/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
6/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
7.5%
3/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
4/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
14.3%
3/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
4/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Nervous system disorders
Dizziness
|
15.0%
9/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
7.5%
3/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Nervous system disorders
Dysgeusia
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Nervous system disorders
Headache
|
20.0%
12/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
7.5%
3/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
14.3%
3/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
7.5%
3/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Psychiatric disorders
Depression
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Psychiatric disorders
Insomnia
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Renal and urinary disorders
Proteinuria
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.7%
7/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
10/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
15.0%
6/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
15.0%
9/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
1.7%
1/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.0%
21/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.3%
2/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
4.8%
1/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
2.5%
1/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
14.3%
3/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Vascular disorders
Hypertension
|
5.0%
3/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
10.0%
4/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
9.5%
2/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
|
Vascular disorders
Hypotension
|
6.7%
4/60 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
5.0%
2/40 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
0.00%
0/21 • Serious and/or other adverse events were assessed from the date of first dose to 40 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
|
Additional Information
Sarah Cannon Development Innovations, LLC
Sarah Cannon Development Innovations, LLC
Phone: 615-329-7274
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place