Trial Outcomes & Findings for A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy (NCT NCT04640623)
NCT ID: NCT04640623
Last Updated: 2026-07-31
Results Overview
Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
220 participants
Primary outcome timeframe
From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Results posted on
2026-07-31
Participant Flow
Participants with high-risk non-muscle invasive bladder cancer (NMIBC) and carcinoma in situ (CIS with or without papillary or papillary only) unresponsive to intravesical bacillus Calmette-Guérin (BCG) who were ineligible for or elected not to undergo radical cystectomy were enrolled in the study. Results are currently reported up to primary completion date 03-Jul-25. Remaining results will be posted upon study completion.
Participant milestones
| Measure |
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).
|
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
85
|
28
|
52
|
|
Overall Study
COMPLETED
|
2
|
7
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
53
|
78
|
28
|
50
|
Reasons for withdrawal
| Measure |
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).
|
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
|
|---|---|---|---|---|
|
Overall Study
Ongoing
|
45
|
66
|
25
|
45
|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
12
|
1
|
5
|
|
Overall Study
Other
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Baseline characteristics by cohort
| Measure |
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)
n=55 Participants
Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).
|
2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)
n=85 Participants
Participants with CIS with or without papillary disease received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=28 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
n=52 Participants
Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Region of Enrollment
GREECE
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=9 Participants
|
24 Participants
n=27 Participants
|
8 Participants
n=267 Participants
|
11 Participants
n=265 Participants
|
54 Participants
n=568 Participants
|
|
Age, Categorical
>=65 years
|
44 Participants
n=9 Participants
|
61 Participants
n=27 Participants
|
20 Participants
n=267 Participants
|
41 Participants
n=265 Participants
|
166 Participants
n=568 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 9.87 • n=9 Participants
|
69.7 years
STANDARD_DEVIATION 9.46 • n=27 Participants
|
68.6 years
STANDARD_DEVIATION 8.73 • n=267 Participants
|
70.1 years
STANDARD_DEVIATION 9.64 • n=265 Participants
|
70.2 years
STANDARD_DEVIATION 9.52 • n=568 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=9 Participants
|
17 Participants
n=27 Participants
|
7 Participants
n=267 Participants
|
15 Participants
n=265 Participants
|
48 Participants
n=568 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=9 Participants
|
68 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
37 Participants
n=265 Participants
|
172 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
14 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=9 Participants
|
76 Participants
n=27 Participants
|
28 Participants
n=267 Participants
|
48 Participants
n=265 Participants
|
204 Participants
n=568 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
22 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=9 Participants
|
74 Participants
n=27 Participants
|
27 Participants
n=267 Participants
|
45 Participants
n=265 Participants
|
191 Participants
n=568 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
3 Participants
n=568 Participants
|
|
Region of Enrollment
AUSTRALIA
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
2 Participants
n=568 Participants
|
|
Region of Enrollment
BELGIUM
|
5 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
19 Participants
n=568 Participants
|
|
Region of Enrollment
CANADA
|
0 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
7 Participants
n=568 Participants
|
|
Region of Enrollment
FRANCE
|
13 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
9 Participants
n=265 Participants
|
38 Participants
n=568 Participants
|
|
Region of Enrollment
GERMANY
|
5 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
5 Participants
n=265 Participants
|
18 Participants
n=568 Participants
|
|
Region of Enrollment
ITALY
|
9 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
24 Participants
n=568 Participants
|
|
Region of Enrollment
JAPAN
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
|
Region of Enrollment
NETHERLANDS
|
1 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
8 Participants
n=568 Participants
|
|
Region of Enrollment
PORTUGAL
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
6 Participants
n=568 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
2 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
5 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
4 Participants
n=265 Participants
|
16 Participants
n=568 Participants
|
|
Region of Enrollment
SPAIN
|
0 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
13 Participants
n=568 Participants
|
|
Region of Enrollment
UNITED STATES
|
12 Participants
n=9 Participants
|
20 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
15 Participants
n=265 Participants
|
56 Participants
n=568 Participants
|
PRIMARY outcome
Timeframe: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)Population: Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study treatment. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Overall CR rate was defined as the percentage of participants who met at least one of the following: negative cystoscopy and negative (including atypical) centrally read urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade non-muscle invasive bladder cancer (NMIBC) and negative (including atypical) centrally read cytology at any time point.
Outcome measures
| Measure |
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=85 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=53 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=28 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
|---|---|---|---|
|
Cohorts 1, 2, and 3: Overall Complete Response (CR) Rate
|
82.4 percentage of participants
Interval 72.6 to 89.8
|
67.9 percentage of participants
Interval 53.7 to 80.1
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
PRIMARY outcome
Timeframe: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)Population: FAS included all enrolled participants who received at least 1 dose of study treatment.
DFS was defined as the time from the date of first dose of study treatment to the time of one of the following events, whichever occurred first: (1) The first recurrence of high-risk disease (high-grade Ta, any T1 or CIS), (2) progression to muscle invasive bladder cancer (MIBC) (T greater than or equal to \[\>=\] 2) or to lymph node (N+) or to distant disease (M+), whichever occurred first, (3) Death due to any cause.
Outcome measures
| Measure |
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=52 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
|---|---|---|---|
|
Cohort 4: Disease-free Survival (DFS)
|
—
|
NA months
Interval 12.12 to
Median and upper bound of 95% confidence interval (CI) were not estimable due to insufficient number of participants with events.
|
—
|
SECONDARY outcome
Timeframe: From onset of first CR up to clinical cut-off date 3rd July 2025 (up to 47.3 months)Population: FAS included all enrolled participants who received at least 1 dose of study treatment. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
DOR was defined as the date of first complete response (CR) achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Complete response was defined as having a negative cystoscopy and negative (including atypical) centrally assessed urine cytology, or positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative (including atypical) centrally assessed cytology at any time point. Number of participants with at least 12 months duration of response were reported.
Outcome measures
| Measure |
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=70 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=36 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=13 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
|---|---|---|---|
|
Cohorts 1, 2, and 3: Number of Participants With at Least 12 Months Duration of Response
|
37 Participants
|
23 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: From Week 0 up to 6 years 7 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose at Week 0 and at any time between Days 2-7 during Weeks 3, 6, 9, 15, 18, and 21 postdosePopulation: FAS was analyzed. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM), "n" (number analyzed) signifies number of participants evaluable at specific timepoints. N=0 because data was not collected or analyzed, as urine was the major pharmacokinetic matrix; therefore, plasma Gemcitabine and dFdU concentrations were not assessed in the Cohort 4. This OM was planned to be analyzed for Cohorts 1, 2, and 4 only.
Plasma concentrations of gemcitabine and dFdU were reported.
Outcome measures
| Measure |
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=80 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=42 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
|---|---|---|---|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Gemcitabine: Week 0 (predose)
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and standard deviation (SD) cannot be reported as the value was below quantification limit (BQL) (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Gemcitabine: Week 9
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Gemcitabine: Week 15
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Gemcitabine: Week 18
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
dFdU: Week 0 (predose)
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
dFdU: Week 9
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Gemcitabine: Week 3
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Gemcitabine: Week 6
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
Gemcitabine: Week 21
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
dFdU: Week 3
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
dFdU: Week 6
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
dFdU: Week 15
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
dFdU: Week 18
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
|
Cohorts 1, 2, and 4: Plasma Concentrations of Gemcitabine and 2',2' Difluorodeoxyuridine (dFdU) (Metabolite)
dFdU: Week 21
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
NA microgram per milliliter (mcg/mL)
Standard Deviation NA
Mean and SD cannot be reported as the value was BQL (\<0.100 mcg/mL).
|
—
|
SECONDARY outcome
Timeframe: At Week 0Population: FAS included all enrolled participants who received at least 1 dose of study treatment. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. This OM was planned to be analyzed for Cohorts 1 and 2 only.
Cmax was defined as maximum observed urine concentration.
Outcome measures
| Measure |
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=21 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=18 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
|---|---|---|---|
|
Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)
Gemcitabine: Week 0
|
12.8 mcg/mL
Standard Deviation 6.52
|
17.4 mcg/mL
Standard Deviation 10.3
|
—
|
|
Cohorts 1 and 2: Maximum Observed Urine Concentration (Cmax) of Gemcitabine and dFdU (Metabolite)
dFdU: Week 0
|
10.6 mcg/mL
Standard Deviation 9.26
|
10.3 mcg/mL
Standard Deviation 11.0
|
—
|
SECONDARY outcome
Timeframe: At Weeks 3, 6, 9, 15, 18, and 21Population: FAS included all enrolled participants who received at least 1 dose of study treatment. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure, "n" (number analyzed) signifies number of participants evaluable at specific timepoints. This OM was planned to be analyzed for Cohort 4 only.
Urine concentrations of gemcitabine and dFdU were reported.
Outcome measures
| Measure |
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=18 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
|---|---|---|---|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
Gemcitabine: Week 15
|
—
|
9.65 mcg/mL
Standard Deviation 9.91
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
Gemcitabine: Week 18
|
—
|
3.65 mcg/mL
Standard Deviation 5.43
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
Gemcitabine: Week 21
|
—
|
0.744 mcg/mL
Standard Deviation 1.58
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
dFdU: Week 3
|
—
|
1.33 mcg/mL
Standard Deviation 2.40
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
dFdU: Week 6
|
—
|
6.12 mcg/mL
Standard Deviation 10.4
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
Gemcitabine: Week 6
|
—
|
2.66 mcg/mL
Standard Deviation 2.13
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
Gemcitabine: Week 9
|
—
|
3.04 mcg/mL
Standard Deviation 6.59
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
Gemcitabine: Week 3
|
—
|
7.91 mcg/mL
Standard Deviation 7.19
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
dFdU: Week 9
|
—
|
6.04 mcg/mL
Standard Deviation 5.45
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
dFdU: Week 15
|
—
|
5.06 mcg/mL
Standard Deviation 5.48
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
dFdU: Week 18
|
—
|
2.09 mcg/mL
Standard Deviation 2.67
|
—
|
|
Cohort 4: Urine Concentration of Gemcitabine and dFdU (Metabolite)
dFdU: Week 21
|
—
|
6.31 mcg/mL
Standard Deviation 6.23
|
—
|
SECONDARY outcome
Timeframe: At Weeks 0, 3, 12, 24, 48, 60, 84 (end of infusion) [EOI]Population: FAS included all enrolled participants who received at least 1 dose of study treatment. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure, "n" (number analyzed) signifies number of participants evaluable at specific timepoints. n=0 indicated that this time point was not applicable for this arm. This OM was planned to be analyzed for Cohorts 1 and 3 only.
Serum concentration of cetrelimab were reported.
Outcome measures
| Measure |
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=27 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=50 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
|---|---|---|---|
|
Cohort 1and 3: Serum Concentration of Cetrelimab
Week 0
|
89.6 mcg/mL
Standard Deviation 23.0
|
101 mcg/mL
Standard Deviation 73.6
|
—
|
|
Cohort 1and 3: Serum Concentration of Cetrelimab
Week 3
|
119 mcg/mL
Standard Deviation 34.0
|
107 mcg/mL
Standard Deviation 30.6
|
—
|
|
Cohort 1and 3: Serum Concentration of Cetrelimab
Week 12
|
155 mcg/mL
Standard Deviation 81.9
|
144 mcg/mL
Standard Deviation 40.0
|
—
|
|
Cohort 1and 3: Serum Concentration of Cetrelimab
Week 24
|
171 mcg/mL
Standard Deviation 47.0
|
155 mcg/mL
Standard Deviation 38.1
|
—
|
|
Cohort 1and 3: Serum Concentration of Cetrelimab
Week 48
|
175 mcg/mL
Standard Deviation 49.7
|
172 mcg/mL
Standard Deviation 66.0
|
—
|
|
Cohort 1and 3: Serum Concentration of Cetrelimab
Week 60
|
NA mcg/mL
Standard Deviation NA
Per plan, data was not summarized when overall number of participants analyzed was less than 3. Therefore, participant wise data is reported in separate OM.
|
146 mcg/mL
Standard Deviation 29.6
|
—
|
|
Cohort 1and 3: Serum Concentration of Cetrelimab
Week 84
|
—
|
44.2 mcg/mL
Standard Deviation 29.0
|
—
|
SECONDARY outcome
Timeframe: At Weeks 60 (EOI)Population: FAS included all enrolled participants who received at least 1 dose of study treatment. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure, "n" (number analyzed) signifies number of participants evaluable at specific timepoints. Per plan, data was not summarized when overall number of participants analyzed was less than 3. Therefore, participant wise data is reported.
Serum concentration of cetrelimab were reported.
Outcome measures
| Measure |
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=2 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
|---|---|---|---|
|
Cohort 3: Serum Concentration of Cetrelimab
Participant 2
|
—
|
121.45383 mcg/mL
Standard Deviation NA
SD cannot be calculated as only one participant was analyzed.
|
—
|
|
Cohort 3: Serum Concentration of Cetrelimab
Participant 1
|
—
|
141.32217 mcg/mL
Standard Deviation NA
SD cannot be calculated as only one participant was analyzed.
|
—
|
SECONDARY outcome
Timeframe: From date of first dose up to clinical cut-off date 3rd July 2025 (54 months)Population: FAS included all enrolled participants who received at least 1 dose of study treatment. Here "N" (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. This OM was planned to be analyzed for Cohorts 1 and 3 only.
Number of participants positive to anti-cetrelimab antibodies was reported using validated immunoassay for anti-drug antibody (ADA) analysis.
Outcome measures
| Measure |
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=28 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=50 Participants
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
|---|---|---|---|
|
Cohorts 1 and 3: Number of Participants With Anti-cetrelimab Antibodies
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From Week 0 up to 6 years 7 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 0 up to 6 years 7 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 0 up to 6 years 7 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 0 up to 6 years 7 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 0 up to 6 years 7 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Week 0 up to 6 years 7 monthsOutcome measures
Outcome data not reported
Adverse Events
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)
Serious events: 17 serious events
Other events: 51 other events
Deaths: 3 deaths
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)
Serious events: 22 serious events
Other events: 78 other events
Deaths: 7 deaths
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
Serious events: 10 serious events
Other events: 44 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)
n=53 participants at risk
Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).
|
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)
n=85 participants at risk
Participants with CIS with or without papillary disease received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=28 participants at risk
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
n=52 participants at risk
Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Aplasia Pure Red Cell
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Atrial Flutter
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Cardiac Failure
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Congenital, familial and genetic disorders
Phimosis
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Hypophysitis
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Volvulus
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema Peripheral
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Immune-Mediated Hepatitis
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Immune system disorders
Anaphylactic Shock
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cystitis Pseudomonal
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
3.8%
2/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pneumonia Aspiration
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Postoperative Abscess
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
3.8%
2/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.8%
2/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection Pseudomonal
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urosepsis
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Device Difficult to Use
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematuria
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Product Issues
Device Occlusion
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Depression
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Bladder Pain
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Bladder Perforation
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Granuloma
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Embolism Venous
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
Other adverse events
| Measure |
Cohort 1: TAR-200 + Cetrelimab (CIS With or Without Papillary Disease)
n=53 participants at risk
Participants with CIS with or without papillary disease, received TAR-200 intravesically every 3 weeks (Q3W) from Week 0 for the first 24 weeks, followed by every 12 weeks (Q12W) dosing through Week 99 in combination with cetrelimab 360 milligrams (mg) intravenously (IV) Q3W from Week 0 through Week 78. TAR-200 was inserted intravesically via the urinary placement catheter (UPC).
|
Cohort 2: TAR-200 Monotherapy (CIS With or Without Papillary Disease)
n=85 participants at risk
Participants with CIS with or without papillary disease received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
|
Cohort 3: Cetrelimab IV Monotherapy (CIS With or Without Papillary Disease)
n=28 participants at risk
Participants with CIS with or without papillary disease, received cetrelimab 360 mg IV Q3W from Week 0 through Week 78.
|
Cohort 4: TAR-200 Monotherapy (Papillary Disease Only)
n=52 participants at risk
Participants with papillary disease only, received TAR-200 intravesically Q3W from Week 0 for the first 24 weeks, followed by Q12W dosing through Week 99. TAR-200 was inserted intravesically via UPC.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
20.8%
11/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
9.4%
8/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
21.4%
6/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.8%
2/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Weight Decreased
|
7.5%
4/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.8%
2/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.3%
6/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.9%
5/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.7%
4/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
7.5%
4/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
11.3%
6/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Asthenia
|
15.1%
8/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
4.7%
4/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
13.5%
7/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
2.4%
2/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.8%
3/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
22.6%
12/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
10.6%
9/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.8%
2/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.8%
11/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
9.4%
8/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
25.0%
7/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.8%
2/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.5%
3/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.8%
2/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
9.4%
5/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
4.7%
4/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
9.4%
5/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.5%
3/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Oedema Peripheral
|
15.1%
8/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
General disorders
Pyrexia
|
15.1%
8/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Covid-19
|
9.4%
5/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
9.4%
8/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
14.3%
4/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Cystitis
|
13.2%
7/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.9%
5/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.7%
4/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
4.7%
4/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
2.4%
2/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
39.6%
21/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
40.0%
34/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
25.0%
7/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
38.5%
20/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
18.9%
10/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
22.6%
12/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Investigations
Lipase Increased
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.9%
5/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
10.7%
3/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.5%
4/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
4.7%
4/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
7.5%
4/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
2.4%
2/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
2.4%
2/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.8%
2/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.5%
3/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
10.7%
3/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
4/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
14.3%
4/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.8%
3/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.2%
1/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
4.7%
4/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.8%
3/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
2.4%
2/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.5%
3/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
2.4%
2/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Bladder Irritation
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.5%
3/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.8%
3/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Bladder Pain
|
18.9%
10/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
9.4%
8/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
9.6%
5/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Bladder Spasm
|
13.2%
7/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
11.8%
10/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
9.6%
5/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
20.8%
11/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
11.8%
10/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.7%
4/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
39.6%
21/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
42.4%
36/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
44.2%
23/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
37.7%
20/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
23.5%
20/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
14.3%
4/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
21.2%
11/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.9%
5/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Micturition Urgency
|
15.1%
8/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
29.4%
25/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
30.8%
16/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Nocturia
|
1.9%
1/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
4.7%
4/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
9.6%
5/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
32.1%
17/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
48.2%
41/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
38.5%
20/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Strangury
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urethral Pain
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
4.7%
4/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.8%
2/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary Incontinence
|
17.0%
9/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
9.4%
8/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.7%
4/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary Retention
|
15.1%
8/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.9%
5/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.8%
2/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
9.4%
5/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
14.1%
12/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.8%
3/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
7.5%
4/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.5%
3/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.8%
3/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.6%
12/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
2.4%
2/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
17.9%
5/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
9.6%
5/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.1%
8/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
2.4%
2/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
1.9%
1/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
7.1%
2/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypertension
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
5.9%
5/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.8%
2/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
|
Vascular disorders
Hypotension
|
5.7%
3/53 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/85 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
3.6%
1/28 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
0.00%
0/52 • All cause mortality: From screening (Day -43) up to clinical cut-off date 3rd July 2025 (up to 51.5 months). TEAEs and other SAEs: From date of first dose up to clinical cut-off date 3rd July 2025 (up to 50 months)
Safety analysis set included all enrolled participants who received at least 1 dose of study treatment.
|
Additional Information
Executive Medical Director
Janssen Research and Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER