Trial Outcomes & Findings for A Study of MK-6598 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-6598-001) (NCT NCT05594043)
NCT ID: NCT05594043
Last Updated: 2026-07-15
Results Overview
DLT is defined as any of the following toxicities, unless assessed by investigator as due to the underlying disease or extraneous causes: Grade (Gr) 4 nonhematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia associated with clinically significant bleeding lasting ≥7 days; Gr 4 anemia of any duration; Nonhematologic AE Gr ≥3 in severity, with exceptions; Any Gr 3/4 nonhematologic lab abnormality if it requires clinically significant medical intervention, leads to hospitalization, persists for \>72 hours, or results in certain drug-induced liver injuries, with some exceptions; Gr 3 or 4 febrile neutropenia; \>2 week delay in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study treatment discontinuation during Cycle 1 (C1), 1 cycle = 21 days; Missing \>25% of MK-6598 doses due to treatment-related AE during C1; Gr 5 toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Up to approximately 21 days
Results posted on
2026-07-15
Participant Flow
Participant milestones
| Measure |
50 mg MK-6598
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
250 mg MK-6598 + Pembrolizumab
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
3
|
9
|
7
|
6
|
6
|
|
Overall Study
Switched Over to MK-8598+Pembrolizumab Treatment
|
0
|
1
|
1
|
6
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
3
|
9
|
7
|
6
|
6
|
Reasons for withdrawal
| Measure |
50 mg MK-6598
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
250 mg MK-6598 + Pembrolizumab
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
3
|
2
|
6
|
6
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
0
|
0
|
1
|
2
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of MK-6598 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-6598-001)
Baseline characteristics by cohort
| Measure |
50 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=3 Participants
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=9 Participants
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
n=7 Participants
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
250 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
24 Participants
n=6 Participants
|
|
Age, Continuous
|
59.5 Years
STANDARD_DEVIATION 6.1 • n=20 Participants
|
64.3 Years
STANDARD_DEVIATION 13.8 • n=20 Participants
|
65.0 Years
STANDARD_DEVIATION 1.0 • n=40 Participants
|
55.0 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
59.4 Years
STANDARD_DEVIATION 12.6 • n=9 Participants
|
62.5 Years
STANDARD_DEVIATION 10.6 • n=6 Participants
|
53.5 Years
STANDARD_DEVIATION 13.0 • n=6 Participants
|
58.9 Years
STANDARD_DEVIATION 11.2 • n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
15 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
39 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
9 Participants
n=5 Participants
|
6 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
35 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 21 daysPopulation: All participants who received at least 1 dose of study intervention and either completed Cycle 1 or experienced a DLT during Cycle 1
DLT is defined as any of the following toxicities, unless assessed by investigator as due to the underlying disease or extraneous causes: Grade (Gr) 4 nonhematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Gr 4 thrombocytopenia of any duration; Gr 3 thrombocytopenia associated with clinically significant bleeding lasting ≥7 days; Gr 4 anemia of any duration; Nonhematologic AE Gr ≥3 in severity, with exceptions; Any Gr 3/4 nonhematologic lab abnormality if it requires clinically significant medical intervention, leads to hospitalization, persists for \>72 hours, or results in certain drug-induced liver injuries, with some exceptions; Gr 3 or 4 febrile neutropenia; \>2 week delay in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study treatment discontinuation during Cycle 1 (C1), 1 cycle = 21 days; Missing \>25% of MK-6598 doses due to treatment-related AE during C1; Gr 5 toxicity.
Outcome measures
| Measure |
50 mg MK-6598
n=3 Participants
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=3 Participants
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=8 Participants
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=4 Participants
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
250 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 24 monthsPopulation: All allocated participants who received at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
Outcome measures
| Measure |
50 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=3 Participants
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=9 Participants
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
n=7 Participants
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
250 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced At Least One AE
|
4 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 24 monthsPopulation: All participants who received at least 1 dose of study intervention
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE will be reported.
Outcome measures
| Measure |
50 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=3 Participants
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=9 Participants
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
n=7 Participants
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
250 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 1, 8, and 15 of Cycle 1: predose, postdose at 30 minutes (min), 45 min, 60 min, 2 hours (hrs), 6 hrs. Days 2 and 9 of Cycle 1: predose.Population: All participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Blood samples were collected at pre-specified time points to determine the AUC0-last of MK-6598 in participant's plasma. AUC0-last of MK-6598 was defined as the area under the concentration-time curve from time 0 to the time of the last quantifiable (above lower limit of quantitation) concentration. AUC0-last was calculated using noncompartmental analysis. Geometric coefficient of variation is calculated in the natural log-scale with the equation:100 x sqrt(exp(σ\^2) - 1), where σ\^2 is the observed variance on the natural log scale.
Outcome measures
| Measure |
50 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=3 Participants
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=9 Participants
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
n=7 Participants
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
250 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
|---|---|---|---|---|---|---|---|
|
Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-6598
Day 1
|
12500 hr*ng/mL
Geometric Coefficient of Variation 40.1
|
33600 hr*ng/mL
Geometric Coefficient of Variation 36.2
|
57700 hr*ng/mL
Geometric Coefficient of Variation 7.5
|
108000 hr*ng/mL
Geometric Coefficient of Variation 63.3
|
11600 hr*ng/mL
Geometric Coefficient of Variation 25.3
|
43500 hr*ng/mL
Geometric Coefficient of Variation 17.0
|
64100 hr*ng/mL
Geometric Coefficient of Variation 11.1
|
|
Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-6598
Day 8
|
26500 hr*ng/mL
Geometric Coefficient of Variation 42.3
|
50800 hr*ng/mL
Geometric Coefficient of Variation 60.3
|
64200 hr*ng/mL
Geometric Coefficient of Variation 25.2
|
144000 hr*ng/mL
Geometric Coefficient of Variation 21.3
|
18100 hr*ng/mL
Geometric Coefficient of Variation 51.5
|
54900 hr*ng/mL
Geometric Coefficient of Variation 44.1
|
94700 hr*ng/mL
Geometric Coefficient of Variation 30.9
|
|
Area Under the Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-6598
Day 15
|
8540 hr*ng/mL
Geometric Coefficient of Variation 23.4
|
13800 hr*ng/mL
Geometric Coefficient of Variation 64.9
|
25500 hr*ng/mL
Geometric Coefficient of Variation 8.3
|
44500 hr*ng/mL
Geometric Coefficient of Variation 24.5
|
7620 hr*ng/mL
Geometric Coefficient of Variation 50.5
|
8520 hr*ng/mL
Geometric Coefficient of Variation 125.3
|
18800 hr*ng/mL
Geometric Coefficient of Variation 85.4
|
SECONDARY outcome
Timeframe: Days 8 and 15 of Cycle 1: predose, postdose at 30 min, 45 min, 60 min, 2 hrs, 6 hrs. Days 2 and 9 of Cycle 1: predose.Population: All participants who complied with the protocol sufficiently to ensure that generated data will be likely to exhibit the effects of treatment, according to the underlying scientific model.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmin. Geometric coefficient of variation is calculated in the natural log-scale with the equation:100 x sqrt(exp(σ\^2) - 1), where σ\^2 is the observed variance on the natural log scale.
Outcome measures
| Measure |
50 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=3 Participants
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=9 Participants
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
n=7 Participants
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
250 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
|---|---|---|---|---|---|---|---|
|
Minimum Serum Concentration (Cmin) of MK-6598
Day 8
|
700 ng/mL
Geometric Coefficient of Variation 80.7
|
1080 ng/mL
Geometric Coefficient of Variation 135.4
|
1120 ng/mL
Geometric Coefficient of Variation 71.4
|
2990 ng/mL
Geometric Coefficient of Variation 24.5
|
546 ng/mL
Geometric Coefficient of Variation 133.9
|
1770 ng/mL
Geometric Coefficient of Variation 38.7
|
2090 ng/mL
Geometric Coefficient of Variation 46.3
|
|
Minimum Serum Concentration (Cmin) of MK-6598
Day 15
|
818 ng/mL
Geometric Coefficient of Variation 11.1
|
363 ng/mL
Geometric Coefficient of Variation 852.0
|
1250 ng/mL
Geometric Coefficient of Variation 47.7
|
1750 ng/mL
Geometric Coefficient of Variation 111.2
|
348 ng/mL
Geometric Coefficient of Variation 165.1
|
590 ng/mL
Geometric Coefficient of Variation 92.8
|
838 ng/mL
Geometric Coefficient of Variation 124.6
|
SECONDARY outcome
Timeframe: Days 1, 8, and 15 of Cycle 1: predose, postdose at 30 min, 45 min, 60 min, 2 hrs, 6 hrs. Days 2 and 9 of Cycle 1: predose.Population: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax. Geometric coefficient of variation is calculated in the natural log-scale with the equation:100 x sqrt(exp(σ\^2) - 1), where σ\^2 is the observed variance on the natural log scale.
Outcome measures
| Measure |
50 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=3 Participants
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=9 Participants
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
n=7 Participants
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
250 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
|---|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of MK-6598
Day 1
|
970 ng/mL
Geometric Coefficient of Variation 29.2
|
2250 ng/mL
Geometric Coefficient of Variation 23.0
|
4200 ng/mL
Geometric Coefficient of Variation 16.7
|
8700 ng/mL
Geometric Coefficient of Variation 22.4
|
815 ng/mL
Geometric Coefficient of Variation 22.0
|
2690 ng/mL
Geometric Coefficient of Variation 21.8
|
4630 ng/mL
Geometric Coefficient of Variation 35.4
|
|
Maximum Serum Concentration (Cmax) of MK-6598
Day 8
|
1560 ng/mL
Geometric Coefficient of Variation 41.3
|
3660 ng/mL
Geometric Coefficient of Variation 28.6
|
4490 ng/mL
Geometric Coefficient of Variation 2.4
|
9670 ng/mL
Geometric Coefficient of Variation 25.5
|
1460 ng/mL
Geometric Coefficient of Variation 45.9
|
4230 ng/mL
Geometric Coefficient of Variation 15.8
|
7070 ng/mL
Geometric Coefficient of Variation 28.8
|
|
Maximum Serum Concentration (Cmax) of MK-6598
Day 15
|
1550 ng/mL
Geometric Coefficient of Variation 21.6
|
3340 ng/mL
Geometric Coefficient of Variation 37.2
|
5090 ng/mL
Geometric Coefficient of Variation 9.3
|
9760 ng/mL
Geometric Coefficient of Variation 18.9
|
1680 ng/mL
Geometric Coefficient of Variation 45.9
|
3140 ng/mL
Geometric Coefficient of Variation 3.2
|
3920 ng/mL
Geometric Coefficient of Variation 86.5
|
SECONDARY outcome
Timeframe: Approximately Day 22Population: All participants who complied with the protocol sufficiently to ensure that generated data likely exhibited the effects of treatment, according to the underlying scientific model.
Tumor core biopsy sample collected during screening period and cycle 2 (21 day cycles) day 1 to determine tumor phenylpyruvate concentration (pmol/mg).
Outcome measures
| Measure |
50 mg MK-6598
n=2 Participants
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=3 Participants
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=2 Participants
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=5 Participants
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
n=5 Participants
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=4 Participants
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
250 mg MK-6598 + Pembrolizumab
n=4 Participants
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
|---|---|---|---|---|---|---|---|
|
Tumor Phenylpyruvate Concentration
|
0.11 pmol/mg
Standard Deviation 0.05
|
6.26 pmol/mg
Standard Deviation 9.50
|
0.51 pmol/mg
Standard Deviation 0.48
|
0.34 pmol/mg
Standard Deviation 0.31
|
0.49 pmol/mg
Standard Deviation .27
|
.30 pmol/mg
Standard Deviation .25
|
.74 pmol/mg
Standard Deviation .84
|
SECONDARY outcome
Timeframe: Days 1, 8, and 15 of Cycle 1: predose, postdose at 30 min, 45 min, 60 min, 2 hrs, 6 hrs. Days 2 and 9 of Cycle 1: predose.Population: All allocated participants who received at least 1 dose of study intervention, were compliant with the study procedures, and had available data from at least 1 treatment dose were analyzed.
Tmax was defined as the time to maximum concentration of MK-6598 observed in plasma. Blood samples were collected pre-dose and post-dose at designated timepoints to determine Tmax of MK-6598.
Outcome measures
| Measure |
50 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=4 Participants
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=3 Participants
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=9 Participants
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
50 mg MK-6598 + Pembrolizumab
n=7 Participants
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
250 mg MK-6598 + Pembrolizumab
n=6 Participants
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months).
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of MK-6598
Day 15
|
2.00 Hours
Interval 0.75 to 2.0
|
2.08 Hours
Interval 0.75 to 6.0
|
2.03 Hours
Interval 1.02 to 2.07
|
3.92 Hours
Interval 1.0 to 5.9
|
1.50 Hours
Interval 0.73 to 2.0
|
1.51 Hours
Interval 1.0 to 2.02
|
1.98 Hours
Interval 0.75 to 5.82
|
|
Time to Maximum Concentration (Tmax) of MK-6598
Day 8
|
5.92 Hours
Interval 1.07 to 6.0
|
1.02 Hours
Interval 0.97 to 2.0
|
2.07 Hours
Interval 2.05 to 6.0
|
2.07 Hours
Interval 1.93 to 5.92
|
1.98 Hours
Interval 0.7 to 6.22
|
2.00 Hours
Interval 1.77 to 5.77
|
2.02 Hours
Interval 1.83 to 2.08
|
|
Time to Maximum Concentration (Tmax) of MK-6598
Day 1
|
6.00 Hours
Interval 1.0 to 6.0
|
1.00 Hours
Interval 0.75 to 6.0
|
2.00 Hours
Interval 1.08 to 2.02
|
5.83 Hours
Interval 1.83 to 6.08
|
5.92 Hours
Interval 1.98 to 6.18
|
2.07 Hours
Interval 1.02 to 6.23
|
3.92 Hours
Interval 1.93 to 5.85
|
Adverse Events
Switch Over to 125 mg MK-6598 + Pembrolizumab
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
50 mg MK-6598 + Pembrolizumab
Serious events: 4 serious events
Other events: 7 other events
Deaths: 6 deaths
125 mg MK-6598 + Pembrolizumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
250 mg MK-6598 + Pembrolizumab
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
Switch Over to 50 mg MK-6598 + Pembrolizumab
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
50 mg MK-6598
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
125 mg MK-6598
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
250 mg MK-6598
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
500 mg MK-6598
Serious events: 3 serious events
Other events: 9 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Switch Over to 125 mg MK-6598 + Pembrolizumab
n=5 participants at risk
Participants that switched over to 125 mg MK-8598+Pembrolizumab treatment
|
50 mg MK-6598 + Pembrolizumab
n=7 participants at risk
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=6 participants at risk
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
250 mg MK-6598 + Pembrolizumab
n=6 participants at risk
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
Switch Over to 50 mg MK-6598 + Pembrolizumab
n=3 participants at risk
Participants that switched over to 50 mg MK-8598+Pembrolizumab treatment
|
50 mg MK-6598
n=4 participants at risk
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=4 participants at risk
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=3 participants at risk
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=9 participants at risk
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Liver function test increased
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Surgical and medical procedures
Assisted suicide
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
Other adverse events
| Measure |
Switch Over to 125 mg MK-6598 + Pembrolizumab
n=5 participants at risk
Participants that switched over to 125 mg MK-8598+Pembrolizumab treatment
|
50 mg MK-6598 + Pembrolizumab
n=7 participants at risk
Participants received MK-6598 QD at 50 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
125 mg MK-6598 + Pembrolizumab
n=6 participants at risk
Participants received MK-6598 QD at 125 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
250 mg MK-6598 + Pembrolizumab
n=6 participants at risk
Participants received MK-6598 QD at 250 mg, plus pembrolizumab 200 mg once every 21-day cycle for up to 35 cycles (up to approximately 24 months)
|
Switch Over to 50 mg MK-6598 + Pembrolizumab
n=3 participants at risk
Participants that switched over to 50 mg MK-8598+Pembrolizumab treatment
|
50 mg MK-6598
n=4 participants at risk
Participants received MK-6598 daily (QD) 50 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
125 mg MK-6598
n=4 participants at risk
Participants received MK-6598 daily (QD) at 125 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
250 mg MK-6598
n=3 participants at risk
Participants received MK-6598 daily (QD) at 250 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
500 mg MK-6598
n=9 participants at risk
Participants received MK-6598 daily (QD) at 500 mg for up to a total of 35 cycles (up to approximately 24 months).
Participants were allowed at the investigator's discretion and after consultation with the Sponsor, to switch over to receive combination treatment of MK-6598 and Pembrolizumab
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Palpitations
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Sinus tachycardia
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.2%
2/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
3/9 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Mouth ulceration
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
1/5 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.2%
2/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.2%
2/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Asthenia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Chest discomfort
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Chest pain
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Chills
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Face oedema
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Facial pain
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
100.0%
3/3 • Number of events 4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
44.4%
4/9 • Number of events 4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Influenza like illness
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Localised oedema
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Malaise
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
40.0%
2/5 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.2%
2/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.2%
2/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Candida infection
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Gastroenteritis
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Skin infection
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Graft complication
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
40.0%
2/5 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Influenza virus test positive
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Oxygen saturation decreased
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Serum ferritin decreased
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Weight decreased
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
Weight increased
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
100.0%
3/3 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
3/9 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
40.0%
2/5 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Malnutrition
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.2%
2/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal wall neoplasm
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.2%
2/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
42.9%
3/7 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.2%
2/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Psychiatric disorders
Panic attack
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Urinary retention
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Reproductive system and breast disorders
Vulval oedema
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
50.0%
3/6 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.2%
2/9 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
1/3 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
28.6%
2/7 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
25.0%
1/4 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Flushing
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Haematoma
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/9 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
33.3%
2/6 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
66.7%
2/3 • Number of events 2 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
22.2%
2/9 • Number of events 3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/5 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/7 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/6 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/4 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
0.00%
0/3 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
11.1%
1/9 • Number of events 1 • Up to approximately 24 months.
All-Cause Mortality was reported for all randomized participants. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer under study was not considered an AE unless it resulted in hospitalization or death. Therefore, MedDRA terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place