Trial Outcomes & Findings for A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors (NCT NCT05551117)
NCT ID: NCT05551117
Last Updated: 2026-02-09
Results Overview
The landmark analysis for 6 month rPFS rate will occur when all participants on Part 1 have been on study for at least 6 months.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
192 participants
Primary outcome timeframe
Assessed every 8 weeks for six months. Six month data reported.
Results posted on
2026-02-09
Participant Flow
Participant milestones
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
91
|
90
|
7
|
4
|
|
Overall Study
Intent-to-treat Population
|
91
|
90
|
7
|
4
|
|
Overall Study
Safety Population
|
90
|
86
|
3
|
4
|
|
Overall Study
Tumor Response Evaluable Population
|
59
|
49
|
3
|
4
|
|
Overall Study
Prostate-specific Antigen (PSA) Response Evaluable Population
|
83
|
71
|
0
|
0
|
|
Overall Study
Anti-drug Antibody (ADA) Evaluable Population
|
90
|
86
|
0
|
4
|
|
Overall Study
COMPLETED
|
58
|
56
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
33
|
34
|
5
|
2
|
Reasons for withdrawal
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Overall Study
Death
|
23
|
20
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
13
|
4
|
0
|
|
Overall Study
Elected to receive vobramitamab duocarmazine after protocol amendment 2.
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors
Baseline characteristics by cohort
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=91 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=90 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
n=7 Participants
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
n=4 Participants
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 9.03 • n=41 Participants
|
69.1 years
STANDARD_DEVIATION 8.94 • n=1581 Participants
|
65.7 years
STANDARD_DEVIATION 10.47 • n=4626 Participants
|
51.8 years
STANDARD_DEVIATION 12.97 • n=1267 Participants
|
69.2 years
STANDARD_DEVIATION 9.45 • n=127 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
3 Participants
n=1267 Participants
|
3 Participants
n=127 Participants
|
|
Sex/Gender, Customized
Male
|
90 Participants
n=41 Participants
|
90 Participants
n=1581 Participants
|
7 Participants
n=4626 Participants
|
1 Participants
n=1267 Participants
|
188 Participants
n=127 Participants
|
|
Sex/Gender, Customized
Undifferentiated
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
1 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
19 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=41 Participants
|
50 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
4 Participants
n=1267 Participants
|
107 Participants
n=127 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=41 Participants
|
32 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
66 Participants
n=127 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
1 Participants
n=1267 Participants
|
8 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
0 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
6 Participants
n=127 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=41 Participants
|
46 Participants
n=1581 Participants
|
6 Participants
n=4626 Participants
|
2 Participants
n=1267 Participants
|
103 Participants
n=127 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
0 Participants
n=1267 Participants
|
1 Participants
n=127 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
36 Participants
n=41 Participants
|
37 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
1 Participants
n=1267 Participants
|
74 Participants
n=127 Participants
|
|
Region of Enrollment
South Korea
|
2 participants
n=41 Participants
|
3 participants
n=1581 Participants
|
1 participants
n=4626 Participants
|
0 participants
n=1267 Participants
|
6 participants
n=127 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=41 Participants
|
5 participants
n=1581 Participants
|
0 participants
n=4626 Participants
|
0 participants
n=1267 Participants
|
9 participants
n=127 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=41 Participants
|
10 participants
n=1581 Participants
|
1 participants
n=4626 Participants
|
4 participants
n=1267 Participants
|
26 participants
n=127 Participants
|
|
Region of Enrollment
Poland
|
8 participants
n=41 Participants
|
8 participants
n=1581 Participants
|
0 participants
n=4626 Participants
|
0 participants
n=1267 Participants
|
16 participants
n=127 Participants
|
|
Region of Enrollment
Italy
|
3 participants
n=41 Participants
|
4 participants
n=1581 Participants
|
0 participants
n=4626 Participants
|
0 participants
n=1267 Participants
|
7 participants
n=127 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=41 Participants
|
4 participants
n=1581 Participants
|
4 participants
n=4626 Participants
|
0 participants
n=1267 Participants
|
14 participants
n=127 Participants
|
|
Region of Enrollment
Australia
|
4 participants
n=41 Participants
|
1 participants
n=1581 Participants
|
1 participants
n=4626 Participants
|
0 participants
n=1267 Participants
|
6 participants
n=127 Participants
|
|
Region of Enrollment
France
|
35 participants
n=41 Participants
|
35 participants
n=1581 Participants
|
0 participants
n=4626 Participants
|
0 participants
n=1267 Participants
|
70 participants
n=127 Participants
|
|
Region of Enrollment
Spain
|
18 participants
n=41 Participants
|
20 participants
n=1581 Participants
|
0 participants
n=4626 Participants
|
0 participants
n=1267 Participants
|
38 participants
n=127 Participants
|
PRIMARY outcome
Timeframe: Assessed every 8 weeks for six months. Six month data reported.Population: All participants according to the study treatment assigned (Intent to Treat Population) for participants with mCRPC in Part 1 only. This outcome measure applies to Part 1 only. Per protocol, participants in Part 2 did not have mCRPC and were not part of this analysis.
The landmark analysis for 6 month rPFS rate will occur when all participants on Part 1 have been on study for at least 6 months.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=91 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=90 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
n=7 Participants
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator
|
0.69 proportion of participants
Interval 0.57 to 0.78
|
0.70 proportion of participants
Interval 0.46 to 0.79
|
0.47 proportion of participants
Interval 0.021 to
upper limit could not be estimated due to insufficient number of events.
|
—
|
PRIMARY outcome
Timeframe: Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.Population: All participants who received at least one dose of study treatment and had RECIST-evaluable disease per RECIST v1.1 (Tumor Response Evaluable Population) in Part 2 of the study.
The ORR is defined as the percentage of participants in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST version 1.1 criterial CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=4 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 2: Objective Response Rate (ORR) Per Investigator Assessment of Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Criteria
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months,Population: The analysis is limited to only participants with mCRPC who experienced a complete or partial response to study treatment. None of the participants in the control arm experienced a complete or partial response to study treatment. Participants in Part 2 did not have mCRPC, so were not eligible for response using PCWG3 criteria.
To qualify as an objective response, CR and PR require confirmation at least 4 weeks after initial observation of complete response (CR) or partial response (PR). CR + PR = ORR
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=59 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=49 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
n=3 Participants
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 1: ORR Per PCWG3 Criteria as Determined by the Investigator
|
13.6 percentage of participants
|
30.6 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.Population: All participants with mCRPC who achieved a confirmed complete or partial response to study treatment. No participants in the control group had a complete or partial response. Participants in Part 2 did not have mCRPC, so were not eligible for response using PCWG3 criteria.
The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented PD or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=8 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=15 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 1: Median Duration of Response (DoR) Per PCWG3 Criteria as Determined by the Investigator
|
9.4 months
Interval 3.68 to
The upper bound of the CI could not be estimated due to insufficient number of participants with events
|
9.1 months
Interval 5.78 to 9.92
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.Population: All participants with mCRPC who received at least one dose of study treatment and had RECIST-evaluable disease per PCWG3 (Tumor Response Evaluable Population) in Part 1 of the study. Participants in Part 2 of the study did not have mCRPC and are excluded from this analysis.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=59 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=49 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
n=2 Participants
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 1: Mean Best Tumor Size Change Over Time
|
-13.0 percent change from baseline
Standard Deviation 59.70
|
-29.0 percent change from baseline
Standard Deviation 33.92
|
-7.44 percent change from baseline
Standard Deviation 7.16
|
—
|
SECONDARY outcome
Timeframe: Every 4 weeks throughout study participation. Average duration 10 months.Population: All participants in Part 1 who received at least one dose of study treatment, with a baseline PSA ≥ 2 ng/mL and at least one post-baseline PSA measurement (PSA Response Evaluable Population). There were no participants in the Control Arm that were part of the PSA Response Evaluable Population. Participants in Part 2 did not have mCRPC, so were not assessed using PSA measurement.
PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=83 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=71 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 1: Prostate-specific Cancer Antigen (PSA) Response Rate Per PCWG3 Criteria
|
45.8 percent
Interval 34.8 to 57.1
|
38.0 percent
Interval 26.8 to 50.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 4 weeks throughout study participation. Average duration of participation, 10 months.Population: The ITT population for Part 1 was used for this analysis. Only 3 of 7 participants were treated in the in the control arm. Of the 3 participants treated in the control arm, only 1 participant had an event. Participants in Part 2 did not have mCRPC, so were not assessed using PSA measurement.
In participants with a decrease in PSA from baseline, PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline, PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks. Time to PSA progression is defined as the time from the date of randomization to the first PSA progression.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=91 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=90 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
n=1 Participants
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 1: Time to PSA Progression Per PCWG3 Criteria
|
5.9 months
Interval 4.63 to 6.97
|
6.9 months
Interval 4.83 to
The upper bound of the CI could not be estimated due to insufficient number of participants with event
|
4.6 months
95% confidence interval could not be calculated for 1 participant.
|
—
|
SECONDARY outcome
Timeframe: Every 4 weeks throughout study participation. Average duration of participation, 10 months.Population: All participants in Part 1 who met criteria for a PSA response to study treatment. There were no participants in the Control Arm that were part of the PSA Response Evaluable Population. Participants in Part 2 did not have mCRPC, so were not assessed using PSA measurement.
Duration of PSA response is defined as the time from the date of first documented PSA response to the earliest date of PSA progression.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=38 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=27 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 1: Duration of PSA Response Per PCWG3 Criteria
|
6.1 months
Interval 4.63 to
The upper bound of the CI could not be estimated due to insufficient number of participants with event
|
NA months
Interval 5.13 to
The median and upper bound of the CI could not be estimated due to insufficient number of participants with events
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 4 weeks throughout study participation. Average duration of participation, 10 months.Population: PSA Response Evaluable Population. There were no participants in the Control Arm that were part of the PSA Response Evaluable Population. Participants in Part 2 did not have mCRPC, so were not assessed using PSA measurement.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=83 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=71 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 1: Best PSA Percent Change
|
-28.7 percent change from baseline
Standard Deviation 67.05
|
-33.1 percent change from baseline
Standard Deviation 70.89
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 4 weeks throughout the study. Average duration of participation, 10 months.Population: Participants who experienced a symptomatic skeletal event in Part 1 of the study. SSE were not assessed in Part 2, as these participants did not have mCRPC.
An SSE is defined as any of the following events: new symptomatic pathological fracture, requirement for radiation therapy to relieve bone pain, spinal cord compression, or tumor-related orthopedic surgical intervention. The time to first SSE is defined as the time from the date of randomization to the first occurrence of SSE.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=5 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=7 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 1: Time to First Symptomatic Skeletal Event (SSE)
|
3.71 days
Standard Deviation 1.984
|
2.80 days
Standard Deviation 2.142
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout the study, average duration of participation, 10 months.Population: The Safety Population was used for this analysis.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=90 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=86 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
n=3 Participants
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
n=4 Participants
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Number of Participants With Adverse Event (AEs), Serious AEs (SAEs), and AEs Leading to Study Treatment Discontinuation.
Serious Adverse Events
|
36 Participants
|
44 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Event (AEs), Serious AEs (SAEs), and AEs Leading to Study Treatment Discontinuation.
Adverse Events Leading to Discontinuation
|
28 Participants
|
41 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Event (AEs), Serious AEs (SAEs), and AEs Leading to Study Treatment Discontinuation.
Any Adverse Event
|
89 Participants
|
86 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Every 4 weeks throughout the study, average duration of participation was 10 months.Population: The ADA Evaluable Population was used for this analysis. Participants in the control arm did not receive MGC018.
Participant specimens were evaluated for the presence of ADA beginning a baseline and throughout the study. If at any time during the study, the results show evidence of ADA, they were counted as ADA positive. There was no time-to- event analysis nor by visit analysis of the data.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=90 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=86 Participants
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
n=4 Participants
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Number of Participants Who Develop Anti-drug Antibodies (ADA)
Positive ADA at baseline
|
0 participants
|
0 participants
|
—
|
0 participants
|
|
Number of Participants Who Develop Anti-drug Antibodies (ADA)
Positive ADA at any time after dosing.
|
22 participants
|
16 participants
|
—
|
0 participants
|
SECONDARY outcome
Timeframe: Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.Population: No participants in Part 2 of the study had a complete or partial response to study treatment.
The DoR will be calculated as the time from the date of initial tumor response (CR or PR) to the date of first documented progressive disease (PD) or death from any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 8 weeks for the first 24 weeks, then every 12 weeks. Average duration of participation, 10 months.PFS is defined as the time from the date of the first dose to the date of first PD per RECIST 1.1 criteria or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=4 Participants
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Part 2: Median Progression Free Survival (PFS) Per Investigator Assessment of RECIST 1.1 Criteria
|
NA months
Cannot be estimated due to insufficient number of events.
|
—
|
—
|
—
|
Adverse Events
Part 1: MGC018 2.0 mg (Arm A)
Serious events: 36 serious events
Other events: 89 other events
Deaths: 25 deaths
Part 1: MGC018 2.7 mg (Arm B)
Serious events: 44 serious events
Other events: 86 other events
Deaths: 21 deaths
Part 1: Control Arm
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part 2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=90 participants at risk
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=86 participants at risk
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
n=3 participants at risk
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
n=4 participants at risk
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
2/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Pericardial effusion
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
5.8%
5/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
4.7%
4/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.2%
2/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
2.3%
2/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Cardiac failure
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Atrial flutter
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Stress cardiomyopathy
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Eye disorders
Dry eye
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
33.3%
1/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Overflow diarrhoea
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
General physical health deterioration
|
2.2%
2/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
3.5%
3/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
Generalised oedema
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
Pyrexia
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
Death
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
Fatigue
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
5.8%
5/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Appendicitis
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Bacteraemia
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
COVID-19
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Erysipelas
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Gastrointestinal infection
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Influenza
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Oral infection
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Sepsis
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Thrombophlebitis septic
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
2/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Investigations
Platelet count decreased
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Metabolism and nutrition disorders
Calcium deficiency
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
2.3%
2/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Nervous system disorders
Ischaemic stroke
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Nervous system disorders
Paraesthesia
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
33.3%
1/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
33.3%
1/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.8%
7/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
14.0%
12/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
3.5%
3/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
2.3%
2/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
3.5%
3/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Vascular disorders
Hypotension
|
0.00%
0/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
1.2%
1/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Vascular disorders
Peripheral ischaemia
|
1.1%
1/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
Other adverse events
| Measure |
Part 1: MGC018 2.0 mg (Arm A)
n=90 participants at risk
vobramitamab duocarmazine 2.0 mg/kg, IV, every 4 weeks
|
Part 1: MGC018 2.7 mg (Arm B)
n=86 participants at risk
vobramitamab duocarmazine 2.7 mg/kg, IV, every 4 weeks
|
Part 1: Control Arm
n=3 participants at risk
abiraterone 1000 mg once daily or enzalutamide 160 mg once daily.
|
Part 2
n=4 participants at risk
vobramitamab duocarmazine 2.7 mg.kg, IV, every 4 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
21.1%
19/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
26.7%
23/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
33.3%
1/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.9%
17/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.6%
22/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.7%
6/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
14.0%
12/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.4%
4/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
11.6%
10/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.4%
4/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
9.3%
8/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Pericardial effusion
|
14.4%
13/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
15.1%
13/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Cardiac disorders
Atrial fibrillation
|
7.8%
7/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
4.7%
4/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Eye disorders
Dry eye
|
11.1%
10/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
11.6%
10/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Eye disorders
Eyelid oedema
|
6.7%
6/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
10.5%
9/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Eye disorders
Lacrimation increased
|
5.6%
5/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
5.8%
5/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Nausea
|
35.6%
32/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
30.2%
26/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
33.3%
1/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.9%
26/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
23.3%
20/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Constipation
|
24.4%
22/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
23.3%
20/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
50.0%
2/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Stomatitis
|
14.4%
13/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
26.7%
23/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
15/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
5.8%
5/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
5/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
10.5%
9/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
6/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
9.3%
8/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Gastrointestinal disorders
Dry mouth
|
7.8%
7/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
3.5%
3/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
Asthenia
|
52.2%
47/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
60.5%
52/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
Oedema peripheral
|
36.7%
33/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
40.7%
35/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
Fatigue
|
27.8%
25/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
23.3%
20/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
66.7%
2/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
50.0%
2/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
Pyrexia
|
12.2%
11/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
14.0%
12/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
Chills
|
5.6%
5/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
8.1%
7/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
General disorders
Face oedema
|
7.8%
7/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
2.3%
2/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Conjunctivitis
|
12.2%
11/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
19.8%
17/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Bronchitis
|
6.7%
6/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
5.8%
5/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Infections and infestations
Herpes zoster
|
4.4%
4/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
7.0%
6/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.4%
4/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
12.8%
11/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Investigations
Weight decreased
|
11.1%
10/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
10.5%
9/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Investigations
Platelet count decreased
|
7.8%
7/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
9.3%
8/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Investigations
Aspartate aminotransferase increased
|
8.9%
8/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
5.8%
5/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
33.3%
1/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Investigations
Neutrophil count decreased
|
5.6%
5/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
7.0%
6/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Investigations
White blood cell count decreased
|
5.6%
5/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
4.7%
4/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.7%
33/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
40.7%
35/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.3%
3/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
7.0%
6/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
33.3%
1/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.4%
13/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
8.1%
7/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
33.3%
1/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
8/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
11.6%
10/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
66.7%
2/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.9%
8/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
9.3%
8/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Nervous system disorders
Headache
|
13.3%
12/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
18.6%
16/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
50.0%
2/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
10/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
12.8%
11/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
9/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
4.7%
4/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Psychiatric disorders
Insomnia
|
3.3%
3/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
11.6%
10/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
27.8%
25/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
33.7%
29/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
10/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
18.6%
16/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.9%
8/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
15.1%
13/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
21.1%
19/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
27.9%
24/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
18.9%
17/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
12.8%
11/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
9/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
8.1%
7/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.9%
8/90 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
5.8%
5/86 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
0.00%
0/3 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
25.0%
1/4 • Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to average duration of participation, 10 months months. All-cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to average duration of participation, 10 months.
Adverse events are based on physical findings, patient reports, and significant laboratory values. Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60