Trial Outcomes & Findings for Atezolizumab in Combination With Entinostat and Bevacizumab in Patients With Advanced Renal Cell Carcinoma (NCT NCT03024437)
NCT ID: NCT03024437
Last Updated: 2025-03-20
Results Overview
Three dose levels of entinostat (1 mg, 3 mg and 5 mg) were tested according to the 3 + 3 standard design. The starting dose level of entinostat was 1 mg orally every 7 days. DLTs attributable to entinostat and/or bevacizumab and/or atezolizumab were evaluated during the first 21 days of the combination treatment. If a DLT occurs in 1 patient treated at the starting dose level, a minimum of 3 additional patients will be treated at this dose level. If DLTs occur in 2 or more of the first 6 patients, the study will be terminated. If a DLT occurs in 1 out of 6 patients, 3 additional patients will be treated at the next dose level (level 2). If no DLTs occur at the starting dose level 1, 3 additional patients will be treated at the next dose level (level 2). The process is repeated for dose level 2. If no DLTs occur at dose level 3 or if 1 DLT occurs out of 6 patients, then this dose level will be recommended for the Phase II portion of the study.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
21 days
Results posted on
2025-03-20
Participant Flow
Participant milestones
| Measure |
Phase I - Dose Level 1
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 1 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 1 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 1 mg.
|
Phase I - Dose Level 2
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 2 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 3 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 3 mg.
|
Phase I - Dose Level 3
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 3 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 5 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase II - Cohort A
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and NO prior treatments.
Patients in Cohort A will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase II - Cohort B
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and at least one prior treatment with a PD1 or PDL1 inhibitor.
Patients in Cohort B will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
12
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
12
|
1
|
Reasons for withdrawal
| Measure |
Phase I - Dose Level 1
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 1 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 1 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 1 mg.
|
Phase I - Dose Level 2
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 2 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 3 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 3 mg.
|
Phase I - Dose Level 3
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 3 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 5 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase II - Cohort A
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and NO prior treatments.
Patients in Cohort A will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase II - Cohort B
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and at least one prior treatment with a PD1 or PDL1 inhibitor.
Patients in Cohort B will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
3
|
5
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Disease progression, relapse
|
1
|
0
|
0
|
3
|
0
|
|
Overall Study
Disease progression, refractory disease
|
4
|
4
|
2
|
2
|
1
|
|
Overall Study
Newly diagnosed cancer
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Moved out of state
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Needed an alternative therapy prohibited by protocol
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Atezolizumab in Combination With Entinostat and Bevacizumab in Patients With Advanced Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Phase I - Dose Level 1
n=6 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 1 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 1 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 1 mg.
|
Phase I - Dose Level 2
n=6 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 2 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 3 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 3 mg.
|
Phase I - Dose Level 3
n=6 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 3 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 5 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase II - Cohort A
n=12 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and NO prior treatments.
Patients in Cohort A will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase II - Cohort B
n=1 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and at least one prior treatment with a PD1 or PDL1 inhibitor.
Patients in Cohort B will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
54.1 years
STANDARD_DEVIATION NA • n=21 Participants
|
57.9 years
STANDARD_DEVIATION 10.1 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
28 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
12 participants
n=4 Participants
|
1 participants
n=21 Participants
|
31 participants
n=8 Participants
|
|
ECOG Performance Status
0
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
ECOG Performance Status
1
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: Patients who received at least one cycle of study drugs and had at least one post-baseline evaluation.
Three dose levels of entinostat (1 mg, 3 mg and 5 mg) were tested according to the 3 + 3 standard design. The starting dose level of entinostat was 1 mg orally every 7 days. DLTs attributable to entinostat and/or bevacizumab and/or atezolizumab were evaluated during the first 21 days of the combination treatment. If a DLT occurs in 1 patient treated at the starting dose level, a minimum of 3 additional patients will be treated at this dose level. If DLTs occur in 2 or more of the first 6 patients, the study will be terminated. If a DLT occurs in 1 out of 6 patients, 3 additional patients will be treated at the next dose level (level 2). If no DLTs occur at the starting dose level 1, 3 additional patients will be treated at the next dose level (level 2). The process is repeated for dose level 2. If no DLTs occur at dose level 3 or if 1 DLT occurs out of 6 patients, then this dose level will be recommended for the Phase II portion of the study.
Outcome measures
| Measure |
Phase I - Dose Escalation
n=18 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Three dose levels of entinostat will be tested in 3-patient cohorts according to the 3 + 3 standard design (1 mg, 3 mg and 5 mg). The starting dose level of entinostat will be 1 mg orally every 7 days.
Atezolizumab: Atezolizumab will be given intravenously every 3 weeks at 1200 mg.
Bevacizumab: Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg.
Entinostat: Entinostat will be given orally every 7 days at 1, 3, or 5 mg depending upon dose escalation cohort. In Phase I, dose levels will be tested in up to 3 cohorts starting at 1 mg.
|
Phase II - Cohort B
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and at least one prior treatment with a PD1 or PDL1 inhibitor.
Patients in Cohort B will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase I - Dose Level 3
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 3 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 5 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
|---|---|---|---|
|
Phase I: Recommended Phase II Dose of Entinostat
|
5 mg
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Patients who received at least one cycle of study drugs and had at least one post-baseline evaluation. Patients who were treated at Dose Level 3 in Phase I were assigned to the applicable Phase II cohort for efficacy analyses.
Percentage of patients who achieved a complete response or partial response to treatment as measured per RECIST 1.1. Complete response: Disappearance of all target lesions. Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Outcome measures
| Measure |
Phase I - Dose Escalation
n=16 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Three dose levels of entinostat will be tested in 3-patient cohorts according to the 3 + 3 standard design (1 mg, 3 mg and 5 mg). The starting dose level of entinostat will be 1 mg orally every 7 days.
Atezolizumab: Atezolizumab will be given intravenously every 3 weeks at 1200 mg.
Bevacizumab: Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg.
Entinostat: Entinostat will be given orally every 7 days at 1, 3, or 5 mg depending upon dose escalation cohort. In Phase I, dose levels will be tested in up to 3 cohorts starting at 1 mg.
|
Phase II - Cohort B
n=3 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and at least one prior treatment with a PD1 or PDL1 inhibitor.
Patients in Cohort B will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase I - Dose Level 3
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 3 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 5 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
|---|---|---|---|
|
Phase II: Percentage of Patients With Objective Response
|
62.5 percentage of participants
Interval 35.4 to 84.8
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Patients who received at least one cycle of study drugs and had at least one post-baseline evaluation.
Percentage of patients who achieved a complete response or partial response to treatment as measured per RECIST 1.1. Complete response: Disappearance of all target lesions. Partial response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Outcome measures
| Measure |
Phase I - Dose Escalation
n=6 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Three dose levels of entinostat will be tested in 3-patient cohorts according to the 3 + 3 standard design (1 mg, 3 mg and 5 mg). The starting dose level of entinostat will be 1 mg orally every 7 days.
Atezolizumab: Atezolizumab will be given intravenously every 3 weeks at 1200 mg.
Bevacizumab: Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg.
Entinostat: Entinostat will be given orally every 7 days at 1, 3, or 5 mg depending upon dose escalation cohort. In Phase I, dose levels will be tested in up to 3 cohorts starting at 1 mg.
|
Phase II - Cohort B
n=5 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and at least one prior treatment with a PD1 or PDL1 inhibitor.
Patients in Cohort B will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase I - Dose Level 3
n=6 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 3 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 5 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
|---|---|---|---|
|
Phase I: Percentage of Patients With Objective Response
|
50 percentage of patients
Interval 11.8 to 88.2
|
20 percentage of patients
Interval 0.5 to 71.6
|
83.3 percentage of patients
Interval 35.9 to 99.6
|
SECONDARY outcome
Timeframe: Up to 4.5 yearsPopulation: Patients who received at least one cycle of study drugs and had at least one post-baseline evaluation. Patients who were treated at Dose Level 3 in Phase I were assigned to the applicable Phase II cohort for efficacy analyses.
Progression free survival was defined as the time from on treatment date to date of recurrence of any type or death from any cause. Patients who did not experience recurrence or death were censored at their last evaluation date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Outcome measures
| Measure |
Phase I - Dose Escalation
n=16 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Three dose levels of entinostat will be tested in 3-patient cohorts according to the 3 + 3 standard design (1 mg, 3 mg and 5 mg). The starting dose level of entinostat will be 1 mg orally every 7 days.
Atezolizumab: Atezolizumab will be given intravenously every 3 weeks at 1200 mg.
Bevacizumab: Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg.
Entinostat: Entinostat will be given orally every 7 days at 1, 3, or 5 mg depending upon dose escalation cohort. In Phase I, dose levels will be tested in up to 3 cohorts starting at 1 mg.
|
Phase II - Cohort B
n=3 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and at least one prior treatment with a PD1 or PDL1 inhibitor.
Patients in Cohort B will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase I - Dose Level 3
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 3 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 5 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
|---|---|---|---|
|
Phase II: Median Progression-free Survival
|
13.7 months
Interval 8.7 to 21.3
|
9.8 months
Interval 1.3 to
The upper limit of the 95% confidence interval could not be estimated due to an insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: Up to 5.5 yearsPopulation: Patients who received at least one cycle of study drugs and had at least one post-baseline evaluation. Patients who were treated at Dose Level 3 in Phase I were assigned to the applicable Phase II cohort for efficacy analyses.
Overall survival was defined as the time from on treatment date to death due to any cause. Patients who remained alive were censored at their last known alive date. The Kaplan-Meier method was used to determine the median and 95% confidence interval.
Outcome measures
| Measure |
Phase I - Dose Escalation
n=16 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Three dose levels of entinostat will be tested in 3-patient cohorts according to the 3 + 3 standard design (1 mg, 3 mg and 5 mg). The starting dose level of entinostat will be 1 mg orally every 7 days.
Atezolizumab: Atezolizumab will be given intravenously every 3 weeks at 1200 mg.
Bevacizumab: Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg.
Entinostat: Entinostat will be given orally every 7 days at 1, 3, or 5 mg depending upon dose escalation cohort. In Phase I, dose levels will be tested in up to 3 cohorts starting at 1 mg.
|
Phase II - Cohort B
n=3 Participants
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and at least one prior treatment with a PD1 or PDL1 inhibitor.
Patients in Cohort B will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase I - Dose Level 3
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 3 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 5 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
|---|---|---|---|
|
Phase II: Median Overall Survival
|
51.6 months
Interval 21.8 to
The upper limit of the 95% confidence interval could not be estimated due to an insufficient number of participants with events.
|
31.2 months
Interval 22.8 to
The upper limit of the 95% confidence interval could not be estimated due to an insufficient number of participants with events.
|
—
|
Adverse Events
Phase I - Dose Level 1
Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase I - Dose Level 2
Serious events: 5 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase I - Dose Level 3
Serious events: 6 serious events
Other events: 6 other events
Deaths: 4 deaths
Phase II - Cohort A
Serious events: 6 serious events
Other events: 12 other events
Deaths: 4 deaths
Phase II - Cohort B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I - Dose Level 1
n=6 participants at risk
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 1 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 1 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 1 mg.
|
Phase I - Dose Level 2
n=6 participants at risk
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 2 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 3 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 3 mg.
|
Phase I - Dose Level 3
n=6 participants at risk
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 3 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 5 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase II - Cohort A
n=12 participants at risk
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and NO prior treatments.
Patients in Cohort A will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase II - Cohort B
n=1 participants at risk
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and at least one prior treatment with a PD1 or PDL1 inhibitor.
Patients in Cohort B will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Endocrine disorders
Endocrine disorders - Other
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Pain
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Lung infection
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Intracranial hemorrhage
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
50.0%
3/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
Other adverse events
| Measure |
Phase I - Dose Level 1
n=6 participants at risk
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 1 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 1 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 1 mg.
|
Phase I - Dose Level 2
n=6 participants at risk
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 2 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 3 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 3 mg.
|
Phase I - Dose Level 3
n=6 participants at risk
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and ANY or NO prior treatments.
Patients in Phase I Dose Level 3 will be treated with atezolizumab, bevaciuzmab, and entinostat at a dose of 5 mg.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase II - Cohort A
n=12 participants at risk
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and NO prior treatments.
Patients in Cohort A will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
Phase II - Cohort B
n=1 participants at risk
Open to patients meeting eligibility criteria with advanced renal cell carcinoma and at least one prior treatment with a PD1 or PDL1 inhibitor.
Patients in Cohort B will be treated with atezolizumab, bevaciuzmab, and the recommended phase II dose of 5 mg of entinostat.
Atezolizumab will be given intravenously every 3 weeks at 1200 mg. Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg. Entinostat will be given orally every 7 days at 5 mg.
|
|---|---|---|---|---|---|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 7 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
50.0%
3/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
50.0%
3/6 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 7 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
4/12 • Number of events 8 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Lipase increased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 5 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
100.0%
1/1 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
4/12 • Number of events 12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
83.3%
10/12 • Number of events 19 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Serum amylase increased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
100.0%
1/1 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
Weight loss
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
50.0%
3/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
50.0%
3/6 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
66.7%
4/6 • Number of events 5 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 5 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Chills
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Edema face
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
100.0%
6/6 • Number of events 10 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
83.3%
5/6 • Number of events 7 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
50.0%
6/12 • Number of events 11 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Fever
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
50.0%
3/6 • Number of events 5 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Gait disturbance
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
General disorders and administration site conditions - Other
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Localized edema
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Eye disorders
Eye disorders - Other
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Eye disorders
Floaters
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
100.0%
1/1 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
66.7%
4/6 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
83.3%
5/6 • Number of events 5 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
83.3%
10/12 • Number of events 25 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
66.7%
4/6 • Number of events 6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
4/6 • Number of events 7 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
66.7%
4/6 • Number of events 6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
66.7%
4/6 • Number of events 5 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
75.0%
9/12 • Number of events 19 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 5 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
66.7%
8/12 • Number of events 11 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Hypersomnia
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Memory impairment
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Nervous system disorders - Other
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
3/6 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
75.0%
9/12 • Number of events 13 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
50.0%
3/6 • Number of events 5 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
3/6 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Vascular disorders
Hypertension
|
33.3%
2/6 • Number of events 3 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
25.0%
3/12 • Number of events 8 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
100.0%
1/1 • Number of events 4 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
1/6 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/12 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
8.3%
1/12 • Number of events 1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/6 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
33.3%
2/6 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
16.7%
2/12 • Number of events 2 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
0.00%
0/1 • Up to 2.5 years for adverse events and up to 5.5 years for all-cause mortality.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place